Skip to main content
OpenTrials
Completed

NCT Number: NCT00586326

MammoSite as Sole Radiation Therapy Technique for Ductal Carcinoma In-Situ

This study has been designed to compile information on the efficacy of the MammoSite RTS providing sole radiation therapy for patients with pure DCIS.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

DCIS Adenocarcinoma Breast Carcinoma In Situ Carcinoma Carcinoma in Situ Carcinoma, Intraductal, Noninfiltrating Neoplasms Neoplasms by Histologic Type Neoplasms, Ductal, Lobular, and Medullary Neoplasms, Glandular and Epithelial

Age range

45 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Phase 2

Primary location

Arizona Oncology Services, Phoenix, Arizona, United States

Loading trial locations.

About this study

Data relevant to the evaluation of the efficacy and safety of the MammoSite RTS system in providing radiation therapy to patients with DCIS will be collected. The MammoSite is a radionuclide applicator designed to deliver internal radiation therapy (brachytherapy) in patients with breast tumors following breast tumor resection surgery (lumpectomy).

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Pre-Surgery:
  • Unicentric pure DCIS
  • Lesions should have a greatest dimension of 3 cm or less as determined by pre-surgery mammography and MRI
  • Post-Surgery:
  • Negative histological margins confirmed prior to beginning radiation therapy.
  • Margins are positive if there is tumor at the inked margin.
  • Classified as low (NG1), intermediate (NG2) or high (NG3) nuclear grade DCIS, using the Philadelphia Consensus Conference Guidelines are eligible
  • Clinically node negative

Exclusion criteria

  • Distance from the balloon surface to the surface of the skin < 5mm as determined by CT imaging.
  • Distant metastases.
  • Invasive or in-situ lobular carcinoma (post-surgery assessment).
  • Nonepithelial breast malignancies such as sarcoma or lymphoma.
  • DCIS that is multicentric in the ipsilateral breast.
  • Pregnant or lactating.
  • Prior non-hormonal therapy for the present breast cancer, including radiation therapy and/or chemotherapy.
  • Collagen vascular diseases
  • Coexisting medical conditions with life expectancy < 2 years.
  • Serious psychiatric or addictive disorder
  • Previously treated contralateral breast carcinoma
  • Synchronous bilateral breast carcinoma.
  • Other malignancy, except non-melanoma skin cancer, < 5 years prior to participation in the study; the disease free interval from any prior carcinoma must be continuous.
  • Patients with diffuse disease

Treatment and study plan

MammoSite Radiation Therapy System

Device

The MammoSite is a balloon catheter that is designed to position a radioactive source inside the lumpectomy cavity. The MammoSite applicator is inserted into the cavity created by the tumor removal surgery. The MammoSite applicator is then inflated and expands to fill the cavity.

Primary outcomes

  1. Local Control Rate for Follow-up Period of 5 Years.

    Time frame: Data collected at the time of implant, radiation therapy, and at the patient's 3 month, 6 month, 1 year, 2 year, 3 year, 4 year and 5 year follow-up visits.

    Failure of local control was defined as a histologically confirmed recurrence (invasive or non-invasive) within the prescription isodose volume. All recurrences were to have histological evaluation per the protocol; however, the case report forms did not provide space for this data to be captured. Ipsilateral axillary, infraclavicular, internal mammary, or supraclavicular recurrence or distant metastases were not considered treatment failures unless accompanied by ipsilateral breast failure.

Secondary outcomes

  1. Overall Survival

    Time frame: At 5 Years

  2. Cause Specific Survival

    Time frame: At 5 Years

  3. Disease Free Survival

    Time frame: At 5 Years

  4. Cosmetic Evaluations Over Time

    Time frame: At 5 Years

    As assessed using the four category Harvard Scale for subjects with an evaluation at the 5 year timepoint

Sponsors and collaborators

Lead sponsor

Hologic, Inc.

Industry

Collaborators

  • University of Southern California

Registry information

Official study title

MammoSite Radiation Therapy System (RTS) as the Sole Radiation Therapy Technique for Ductal Carcinoma In-Situ (DCIS)

Acronym: DCIS

Important dates

Study start
2003
Primary completion
2006
Study completion
2011
First posted
Jan 4, 2008
Registry last updated
Nov 6, 2012

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.